Position Summary
100% Onsite - HQ-Thousand Oaks (USTO)
The Scientist, Attribute Sciences, Process Development develops, qualifies, and transfers phase-appropriate analytical methods supporting small molecule and antibody-drug conjugate (Client) drug substance and drug product development from early clinical through commercial stages. The role collaborates closely with Process Development DS/DP teams to ensure methods are scientifically sound and compliant with regulatory requirements.
Education
Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, Chemistry, or related scientific discipline with 1 3 years of industry experience; or
M.S. with 4 6 years of relevant pharmaceutical industry experience; or
B.S. with 6 8 years of relevant pharmaceutical industry experience.
Required Technical Experience
Hands-on experience with HPLC/UHPLC, LC-MS/MS, GC, KF, UV-Vis, FTIR, and related analytical techniques.
Strong knowledge of method development, qualification, validation, and transfer.
Experience supporting small molecule and antibody-drug conjugate (Client) development including impurity characterization, stability studies, and DS/DP analytical activities.
Key Responsibilities
Develop, optimize, troubleshoot, and qualify analytical methods for characterization, release, stability, and process support.
Develop stability-indicating methods for critical quality attributes, including assay, impurities, dissolution, water content.
Support small molecule and Client process development, optimization, technology transfer, and control strategy development.
Characterize intermediates, starting materials, drug substances, and drug products for small molecules and Client programs.
Build process understanding through impurity profiling and material characterization.
Plan and execute method qualification and validation in accordance with ICH guidelines.
Ensure methods are robust, reproducible, and fit for purpose across the product lifecycle.
Analyze experimental data using sound scientific and statistical approaches.
Maintain accurate documentation in ELNs and laboratory information systems.
Author technical reports, development summaries, p